Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592706
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : April 16, 2020
Sponsor:
Collaborator:
Tri-Service General Hospital
Information provided by (Responsible Party):
Ivy Life Sciences, Co., Ltd

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in：

  1. Reduction of tumor size
  2. Reducing the relapse rate: Reducing the frequency of TACE treatment by IKC injections.

Condition or disease Intervention/treatment Phase
HepatoCellular Carcinoma Liver Cancer Biological: IKC (Immune Killer Cells) Procedure: TACE (Transcatheter Arterial Chemoembolization) Phase 2 Phase 3

Detailed Description:

This is a phase II/III clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of twelve infusions.

60 patients are anticipated to be recruited. This is a double-arm study, the experimental group will receive IKC treatment along with TACE treatment. The control group will receive only TACE treatment. 30 patients will be randomized into each arm.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II/III Clinical Trial With Ex Vivo Expanded Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
Actual Study Start Date : December 2009
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: IKC and TACE
IKC (Immune Killer Cells) and TACE(Transcatheter Arterial Chemoembolization)
 Biological: IKC (Immune Killer Cells)
Other Name: Autologous Immune Killer Cells

Procedure: TACE (Transcatheter Arterial Chemoembolization)
Other Name: TACE
Active Comparator: TACE
TACE (Transcatheter Arterial Chemoembolization)
 Procedure: TACE (Transcatheter Arterial Chemoembolization)
Other Name: TACE


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change of tumor size [ Time Frame: One year ]
    Evaluate the efficacy of autologous immune killer cells using Response Evaluation Criteria in Solid Tumors (RECIST) by recording net changes of tumor sizes

  2. Progression-Free Survival (PFS) [ Time Frame: One year ]
    The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse


Secondary Outcome Measures :
  1. Improvement of immune responses [ Time Frame: One year ]
    Evaluate the efficacy and safety of in vitro proliferating autoimmune killer cells as adjuvant therapy for the treatment of liver cancer patients and promote anti-cancer immune responses


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign and give written informed consent.
  2. Age≧20 years, but<80 years.
  3. Hepatocellular carcinoma by CT, MRI, AFP, angiography or cytology/biopsy examinations.
  4. Barcelona staging system stage B and C.
  5. Never receive TACE treatment and comply with the standard of TACE treatment.
  6. Child-Pugh stage A and B.
  7. ECOG performance status 0 to 2.

Exclusion Criteria:

  1. Participant of other clinical trial within the past 4 weeks of screening period.
  2. Receiver of chemotherapy, radiotherapy, immunotherapy, hormone therapy, local tumor therapy, or target therapy within the past 4 weeks of screening period.
  3. Carriers of HIV or HTLV within the past 4 weeks of screening period.
  4. With Active acute or chronic infection by (investigator's judgement).

  5. Other diseases, except hepatocellular carcinoma, which are life-threatening to the patients (by investigator's judgement) for example:

    5.1 Active cardiac disease requiring therapy for coronary artery disease, congestive heart failure, arrhythmia or myocardial infarction.

    5.2 With previous history of encephalopathy within the past six months.

    5.3 Involved Involving systemically or known central nerve system diseases(brain or meningeal metastasis).

  6. Women of pregnant or breast-feeding or child-bearing potential but without adequate contraception.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592706


Contacts
Layout table for location contacts
Contact: Executive Assistant (02)8981-3333 ext 114 thesteve@ivy-cd56.com

Locations
Layout table for location information
Taiwan
Tri Service General Hospital Recruiting
Taipei, Taiwan
Contact: Chung-Bao Hsieh, MD    02-87923311 ext 17245    albert0920@yahoo.com.tw   
Principal Investigator: Chung-Bao Hsieh, MD         
Sponsors and Collaborators
Ivy Life Sciences, Co., Ltd
Tri-Service General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chung-Bao Hsieh, MD Tri-Service General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ivy Life Sciences, Co., Ltd
ClinicalTrials.gov Identifier: NCT03592706    
Obsolete Identifiers: NCT01024530
Other Study ID Numbers: IVY02
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivy Life Sciences, Co., Ltd:
HepatoCellular Carcinoma
Liver Cancer
Immune Killer Cells
IKC
Immune Therapy
 Immunotherapy
Cell Therapy
IVY
IVY02
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Hepatocellular
Liver Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases